Class 3 Device Recall Staarvisc

• Date Initiated by Firm: October 08, 2003
• Date Posted: November 13, 2003
• Recall Status: Terminated on August 09, 2004
• Recall Number: Z-0109-04
• Recall Event ID: 27457
• PMA Number: P000046
• Product Classification: Aid, Surgical, Viscoelastic - Product Code LZP
• Product: Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA
• Code Information: Lot Number: B020122E
• Recalling Firm/ Manufacturer: Anika Therapeutics; 240 West Cummings Park; Woburn MA 01801
• For Additional Information Contact: Julie Broderick; 781-932-6616 Ext. 107
• Manufacturer Reason for Recall: Stability failure at the 20 month for viscosity specification
• FDA Determined Cause: Other
• Action: Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.
• Quantity in Commerce: 1526 units
• Distribution: CA, MO, NC,VA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LZP